Jonathan Saksek v. Janssen Pharm., Inc. (In re Risperdal Litig.)

223 A.3d 633

IN RE: RISPERDAL LITIGATION

Jonathan Saksek, Appellant

v.Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, Janssen Research and Development, LLC, Appellees

In re: Risperdal Litigation

Joshua Winter, Appellant

v.Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, Janssen Research and Development, LLC, Appellees

No. 22 EAP 2018

No. 23 EAP 2018

Supreme Court of Pennsylvania.

Argued: May 16, 2019

Decided: November 20, 2019

OPINION

JUSTICE DONOHUE

In this consolidated appeal, Appellants Jonathan Saksek ("Saksek") and Joshua Winter ("Winter") challenge the ruling of the Superior Court affirming the trial court's grant of summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, "Janssen"). Saksek and Winter are two of a large number of men who have filed suit against Janssen alleging that they developed gynecomastia (enlarged breasts in men) as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which, although nominally directed at Saksek's and Winter's cases, were couched in terms directed at all of the Risperdal plaintiffs – seeking a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims, including those of Saksek and Winter, accrued no later June 31, 2009. The Superior Court disagreed, ruling that all such claims accrued no later than Janssen's preferred date (October 31, 2006). Concluding that the Superior Court erred in granting summary judgment at all in Saksek's and Winter's cases, we vacate its decision and remand to the trial court for further proceedings consistent with this decision.

I. RELEVANT BACKGROUND

A. Risperdal

Risperdal ®, also known in its generic form as risperidone, is a second-generation antipsychotic prescription medication. It is manufactured and sold by Janssen Pharmaceuticals, Inc., a wholly owned and independently managed subsidiary of Johnson & Johnson Company. The federal Food and Drug Administration ("FDA") first approved Risperdal in 1993 for certain adult uses, like schizophrenia. At the time that Risperdal was prescribed to Saksek and Winter, it was for an "off label" use because the FDA had not approved its use either for children generally or for any condition from which they were suffering. The FDA subsequently approved Risperdal for a number of other diseases and patient populations, including in 2003 for bipolar disorder in adults, in 2006 for irritability associated with autistic disorder in children and adolescents aged 5-16 years, and in 2007 for schizophrenia in adolescents aged 13-17 years and bipolar disorder in children and adolescents aged 10-17.

Gynecomastia is an endocrine disorder that is characterized by "swelling of the breast tissue in boys or men, caused by an imbalance of the hormones estrogen and testosterone." Enlarged Breasts in Men (Gynecomastia) , Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/gynecomastia /symptoms-causes/syc- 20351793 (last visited Oct. 28, 2019). Janssen does not dispute that Risperdal sometimes causes hyperprolactinemia, an elevation of prolactin, a hormone secreted by the pituitary gland. Prolactin sometimes suppresses testosterone, which in turn boosts estrogen, both of which may result in the development of breast tissue. Stange v. Janssen Pharmaceuticals, Inc. , 179 A.3d 45, 54-55 (Pa. Super. 2018).

In the prescribing insert (sometimes referred to as the drug's "label") for Risperdal prior to 2006 (during the time when Saksek and Winter were taking the drug), there was no mention of hyperprolactinemia or gynecomastia in either its ‘‘WARNINGS" or "ADVERSE REACTIONS" sections. In the "PRECAUTIONS" section, the label provided as follows:

Hyperprolactinemia : As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.... Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients.

Saksek's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 4 at 7. In a section entitled "Other Events Observed During the Pre-Marketing Evaluation of Risperdal," gynecomastia was identified as an endocrine disorder and a "rare" adverse event. Id. at 19.

When the FDA approved Risperdal for pediatric use in October 2006, the label was changed to provide:

Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

* * * Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin elevating compounds.

* * *

In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorder treated with risperidone, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of Risperdal-treated patients.

Id. Ex. 6 at 15, 24.

B. The Saksek and Winter Claims

Saksek was born in 1987. He grew up in and continues to reside in Hazelton, Pennsylvania. In 1998, at age 11, his psychiatrist prescribed Risperdal in connection with diagnoses for attention deficit hyperactivity disorder and bipolar disorder. Janssen's Motion for Summary Judgment (Saksek), 8/18/2014, Ex. 1 at 5. He discontinued the use of Risperdal in 2004. Id. On February 4, 2014, Saksek filed a short-form complaint, id. Ex. 2, which in turn incorporated by reference a master long-form complaint developed and amended over time by the plaintiffs in the mass-tort litigation.¹ Id. Ex. 11. The master long-form complaint asserts twelve claims based on state common law, products liability and deceptive trade practices,² all based upon the allegation that Janssen failed to warn plaintiffs and their prescribers about the risks associated with Risperdal. Id. In a "Plaintiff's Fact Sheet" attached as an exhibit to the long-form complaint, Saksek reported that in 2001 through 2002, he became aware, through "visual observation," of increased breast size, extreme weight gain, and psychological and emotional distress. Id. Ex. 1 at 7.

Winter was born in May 1980 in Harrisburg, Pennsylvania and continues to reside there. In 1997, Winter began taking Risperdal to control anger management issues. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, Ex.1 at 4. He stopped using Risperdal in 1998. Id. In his short-form complaint, Winter represented that he suffered from weight gain and diabetes while taking Risperdal. Id. Ex. 5 at 2-4. In his "Plaintiff's Fact Sheet," Winter reported that in 1998, he perceived, through "self-observation," that he was experiencing breast development and psychological and emotional distress. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, Ex.1 at 6.

In connection with the filing of their complaints, both Saksek and Winter submitted affidavits swearing that, inter alia, (1) they filed their complaints after being informed by their mothers who had viewed a television commercial in 2013 describing the relationship between gynecomastia and Risperdal ; (2) they are not medical professionals and did not know anything about Risperdal other than that it had been prescribed to them; (3) they followed their doctors' instructions in taking Risperdal ; (4) no doctor told them or their parents that their breast growth and weight gain could have been caused by anything to which they were exposed or ingested; (5) no doctor ever told them or their parents that Risperdal was the cause of their breast growth and weight gain; and (6) they now understood that their breast growth is referred to as gynecomastia, a term they had never heard of until shortly before signing their affidavits. Saksek's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 3; Winter's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 3.

C. Janssen's Partial Motions for Summary Judgment

On May 19, 2014, Janssen filed a motion for partial summary judgment on the issue of the statute of limitations on a global basis (without naming any individual plaintiffs). Therein, Janssen asked the trial court to enter an order holding, inter alia, that all plaintiffs were on constructive and/or inquiry notice of a potential connection between Risperdal use and gynecomastia by no later than October 31, 2006, and that for any gynecomastia injury prior to October 31, 2006 any applicable tort or product liability statute of limitations began to run no later than October 31, 2006. Janssen's Motion for Partial Summary Judgment as to the Affirmative Defense of the Statute of Limitations, 5/19/2015, Proposed Order. The parties fully briefed this global motion, but the trial court did not issue a ruling.

On August 18, 2014, Janssen filed motions for summary judgment in the Winter and Saksek cases. Janssen incorporated by reference the arguments in its global summary judgment motion into these motions. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, at 8 n.10; Janssen's Motion for Summary Judgment (Saksek), 8/18/2014, at 8 n.9. In its moving papers, Janssen contended that both plaintiffs were placed on inquiry notice of their potential Risperdal claim by no later than October 31, 2006 as a result of the drug's label change. On January 13, 2015, the trial court entered an order and opinion granting Janssen's motion for summary judgment in the Winter case, ruling in the opinion that any claim filed after June 31, 2009 must be dismissed on statute of limitations grounds based upon the cumulative effect of medical literature, newspaper articles and attorney...